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MedTech Outlook | Wednesday, March 04, 2020
Firma Clinical Research's director of clinical operations, Nikki Skirvin, describes some of the specific obstacles of running a multi-national study, as well as critical considerations and solutions that can help speed the process
FREMONT, CA: Any clinical trial is a complicated operation; when that study is conducted at several locations across multiple countries, the complexity skyrockets. Firma Clinical Research's director of clinical operations, Nikki Skirvin, describes some of the specific obstacles of running a multi-national study, as well as critical considerations and solutions that can help speed the process.
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More recently, the discussion has switched to how home trial visits can be incorporated into the protocol from the start of the study. Due to the pandemic, home trial visits have become more common, allowing teams to see the long-term benefits of including the services from the outset. Offering patients the option of a home trial as part of the initial protocol has made studies considerably more patient-centric. Conducting home trial visits all across the world might be difficult.
The General Data Protection Regulation (GDPR) of the European Union (EU) may demand that trial data be kept in the nation of origin, which means that the worldwide partner must have a physical presence there. The EU GDPR may also establish more stringent requirements for the handling of personal health information (PHI) and personally identifiable information (PII). Home trial visits may be limited or prohibited due to cultural constraints. To finish some visits in particular places, certain expertise like MD may be necessary.
Some countries prohibit the administration of investigational products (IP) outside of a medical facility, particularly in the case of IP IV infusion administration, which they consider too difficult to be performed at home. Firma is equipped to meet these challenges because of its solid infrastructure and extensive experience in the field. They have a data protection officer who is actively involved in negotiating the GPDR subtleties, local nurses who understand the cultural nuances, and a database with the current legislative and cultural context. This, combined with project managers with in-home health experience, allows them to thrive at multi-national home health studies.
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